Randomized Trial of Interventions to Improve Warfarin Adherence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better control of their anticoagulation therapy. Selection for the arms of the study is randomized by the study computer. Some will participate in the daily lottery only, some with the reminder system only, some with the reminder system and the daily lottery, and some with neither the lottery nor the reminder system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testing Strategies to Improving Warfarin Adherence

NCT00622102

Atrial Fibrillation Deep Venous Thrombosis Dilated Cardiomyopathies

COMPLETED NA

Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation

NCT01578044

Atrial Fibrillation

COMPLETED NA

Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

NCT02836652

Heart Failure

COMPLETED PHASE4

3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE

NCT00365950

Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism

COMPLETED PHASE4

Predictors of Anticoagulation Control on Warfarin Therapy

NCT00905177

Atrial Fibrillation Deep Vein Thrombosis Heart Valve Replacement

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Eligible subjects will be enrolled in one of the 4 arms of the RCT and followed for 6 months, with the primary outcome of out-of-range INRs. Subjects will be given a Med-eMonitor to connect to their home phone line. For all subjects, these will be used to measure daily adherence. Subjects in the incentive group will be eligible for a daily lottery prize only if, prior to the lottery being resolved, their adherence device has registered adherence to their prescribed warfarin regimen. Subjects in the MM group will have the reminder/feedback features of the Med-eMonitor turned on to provide reminders to take their warfarin as prescribed and standardized messages that will be used to provide feedback in response to their adherence. Subjects in the combined group will be exposed to both the lottery and the activated Med-eMonitor. This trial is a randomized controlled trial.

Both men and women who are at least 18 years of age and have been prescribed anticoagulation medication are eligible to participate.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Deep Vein Thrombosis Dilated Cardiomyopathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 Usual Care Group/Control

Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.

Group Type OTHER

Financial Incentive and Med-eMonitor

Intervention Type BEHAVIORAL

Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.

Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.

2Med-eMonitor/Reminder

Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.

Group Type EXPERIMENTAL

2Med-eMonitor

Intervention Type DEVICE

Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.

3 Incentive Group/Lottery

Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.

Group Type EXPERIMENTAL

Financial Incentive and Med-eMonitor

Intervention Type BEHAVIORAL

Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.

Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.

4 Combined Group/Lottery and Reminder

Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.

Group Type EXPERIMENTAL

Financial Incentive and Med-eMonitor

Intervention Type BEHAVIORAL

Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.

Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Financial Incentive and Med-eMonitor

Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.

Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she is taking his/her medication for the day. The device registers their answers and sends the compliance information via the participants' telephone line nightly to a central study server.

Intervention Type BEHAVIORAL

2Med-eMonitor

Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

The study population will include all patients at the study sites who:

1. are in the maintenance phase of their warfarin treatment (defined using the standard method as the period of time following 2 consecutive visits, at least 7 days apart, of stable target INR after initiation of the drug)
2. whose providers indicate are expected to stay on treatment for at least 6 months
3. have a target INR of 2 to 3.5
4. had at least one INR out of the participant's target range within 90 days prior to enrollment (excluding the baseline visit) and/or INR at the baseline visit was below the participant's target range
5. have a working analog telephone line.

Of note, patients do not have to be within their target INR range to enroll; we specifically want to include those who are below the target range at the time of study entry because they may be the patients most likely to be non-adherent.

1. have an INR at screening above the target range
2. are less than 18 years of age and cannot or will not give consent
3. cannot read above a 6th grade reading level
4. are enrolled in a clinical trial of warfarin therapy
5. are unable to adequately follow study procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No